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United States Patent |
5,088,979
|
Filipi
,   et al.
|
February 18, 1992
|
Method for esophageal invagination and devices useful therein
Abstract
A technique for invaginating the esophagus at the gastroesophageal junction
is disclosed, as well as an invagination device useful in the described
technique. The invagination device includes an introducer guide which has
an outside diameter approximating that of the esophagus and a plurality of
needle-receiving lumens extending to its outer diametric surface. The
invagination device also has an engagement assembly which includes 10
needles, each having a retracted position in which they lie within the
needle-receiving lumens of the introducer guide, and an extended position
in which they extend out of the lumens and project radially from the guide
for engagement with the esophagus at the gastroesophageal junction. The
invagination device is introduced transorally into the esophagus, its
engagement assembly is activated to place the needles in their extended
position in engagement with the esophagus, and the engaged invagination
device is advanced the toward the stomach to fold the attached esophagus
beyond the gastroesophageal junction. A remotely operable fastening
assembly, which has been introduced into the stomach through an operating
channel/insufflation port, is then operated to fasten the invaginated
gastroesophageal junction to the surrounding involuted fundic wall.
Finally, the needles are retracted back into their needle-receiving lumens
and the invagination device and the fastening assembly are removed from
the body of the patient. This minimally-invasive technique accomplishes
the formation of a new valve between the esophagus and stomach, thus
preventing acid reflux.
Inventors:
|
Filipi; Charles J. (Marshalltown, IA);
DeMeester; Tom R. (San Marino, CA);
Gibbs; Rebecca C. (Burlington, NC);
Hinder; Ronald A. (Omaha, NE)
|
Assignee:
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Wilson-Cook Medical Inc. (Winston-Salem, NC)
|
Appl. No.:
|
608339 |
Filed:
|
November 2, 1990 |
Current U.S. Class: |
604/26; 604/174 |
Intern'l Class: |
A61M 037/00 |
Field of Search: |
604/26,174
128/4
|
References Cited
U.S. Patent Documents
3817251 | Jun., 1974 | Hasson | 604/26.
|
4077412 | Mar., 1978 | Moosun | 604/174.
|
4207872 | Jun., 1980 | Meiri et al. | 128/4.
|
4240411 | Dec., 1988 | Hosono | 128/4.
|
5002557 | Mar., 1991 | Hasson | 604/26.
|
Primary Examiner: Grieb; William H.
Attorney, Agent or Firm: Woodard, Emhardt, Naughton, Moriarty & McNett
Parent Case Text
REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part of pending U.S. patent
application Ser. No. 07/595,977, filed on Oct. 11, 1990 and entitled
Method and Device for Esophageal Invagination.
Claims
What is claimed:
1. A method for invaginating the gastroesophageal junction of a patient,
said method comprising the steps of:
introducing an invagination device transorally into the esophagus, the
invagination device including an introducer guide and an engagement
assembly; the introducer guide having an outside diameter approximating
that of the esophagus; the engagement assembly including a plurality of
needles, the needles having a retracted position in which the needles lie
within the introducer guide, and an extended position in which the needles
extend out of the introducer guide, projecting radially therefrom, the
engagement assembly further including means for projecting the needles out
of the introducer guide and into engagement with the esophagus in the
vicinity of the gastroesophageal junction;
activating the engagement assembly to place the needles in their extended
position in engagement with the esophagus in the vicinity of the
gastroesophageal junction;
advancing the engaged invagination device toward the stomach to invaginate
the gastroesophageal junction into the stomach, involuting the surrounding
fundic wall;
introducing a remotely operable fastening assembly into the stomach and
operating the fastening assembly to secure the invaginated
gastroesophageal junction to the surrounding involuted fundic wall;
deactivating the engagement assembly to retract the extended needles from
engagement and back into the needle-receiving lumens of the introducer
guide; and
removing the invagination device and the fastening assembly from the body
of the patient.
2. The method of claim 1 additionally including the step of introducing a
guide wire into the esophagus, said guide wire extending out the mouth and
into the stomach, and wherein said step of introducing an invagination
device includes the step of passing the invagination device over the guide
wire through a central lumen defined by the invagination device.
3. The method of claim 2 additionally including the steps of extending the
guide wire through the esophagus and both out the mouth and percutaneously
out of the stomach, and applying tension to the so extended guide wire,
and where said step of passing the invagination device over the guide wire
is conducted while said tension is being applied to the guide wire.
4. The method of claim 1 wherein the needles, when extended out of the
introducer guide, project radially and forwardly from the guide for
engagement with the gastroesophageal junction.
5. The method of claim 1 additionally including the step of endoscopically
observing the invagination device within the esophagus.
6. The method of claim 5 wherein the invaginator device is optically marked
at a predetermined position in relation to its distal end.
7. A method for invaginating the gastroesophageal junction of a patient,
said method comprising the steps of:
introducing an invagination device transorally into the esophagus, the
invagination device including an introducer guide and an engagement
assembly; the introducer guide having an outside diameter approximating
that of the esophagus, the introducer guide further having a plurality of
needle-receiving lumens extending to the outer diametric surface of the
guide; the engagement assembly including a plurality of needles, the
needles having a retracted position in which the needles lie within the
needle-receiving lumens, and an extended position in which the needles
extend out of the lumens and project radially from the guide, the
engagement assembly further including means for projecting the needles out
of the lumens and into engagement with the esophagus in the vicinity of
the gastroesophageal junction;
activating the engagement assembly to place the needles in their extended
position in engagement with the esophagus in the vicinity of the
gastroesophageal junction;
advancing the engaged invagination device toward the stomach to invaginate
the gastroesophageal junction into the stomach, involuting the surrounding
fundic wall;
introducing a remotely operable fastening assembly into the stomach and
operating the fastening assembly to secure the invaginated
gastroesophageal junction to the surrounding involuted fundic wall;
deactivating the engagement assembly to retract the needles from engagement
and back into the needle-receiving lumens of the introducer guide; and
removing the invagination device and the fastening assembly from the body
of the patient.
8. The method of claim 7 additionally including the step of introducing a
guide wire into the esophagus, said guide wire extending out the mouth and
into the stomach, and wherein said step of introducing an invagination
device includes the step of passing the invagination device over the guide
wire through a central lumen defined by the invagination device.
9. The method of claim 8 additionally including the steps of extending the
guide wire through the esophagus and both out the mouth and percutaneously
out of the stomach, and applying tension to the so extended guide wire,
and where said step of passing the invagination device over the guide wire
is conducted while said tension is being applied to the guide wire.
10. The method of claim 8 wherein the needles, when extended out of their
respective lumens, project radially and forwardly from the guide for
engagement with the esophagus.
11. The method of claim 7 additionally including the step of endoscopically
observing the invagination device within the esophagus.
12. The method of claim 11 wherein the invagination device is optically
marked at a predetermined position in relation to its distal end.
13. A method for invaginating the gastroesophageal junction of a patient,
said method comprising the steps of:
opening at least one operating channel port into the stomach, said port
being of sufficient size to accommodate a remotely operable fastening
assembly;
introducing an invagination device transorally into the esophagus, the
invagination device including an introducer guide and an engagement
assembly; the introducer guide having an outside diameter approximating
that of the esophagus, the introducer guide further having a plurality of
needle-receiving lumens extending to the outer diametric surface of the
guide; the engagement assembly including a plurality of needles, the
needles having a retracted position in which the needles lie within the
needle-receiving lumens, and an extended position in which the needles
extend out of the lumens and project radially from the guide, the
engagement assembly further including means for projecting the needles out
of the lumens and into engagement with the gastroesophageal junction;
activating the engagement assembly to place the needles in their extended
position in engagement with the gastroesophageal junction;
advancing the engaged invagination device toward the stomach to invaginate
the gastroesophageal junction into the stomach, involuting the surrounding
fundic wall;
introducing a remotely operable fastening assembly through the opened
operating channel port into the stomach and operating the fastening
assembly to secure the invaginated gastroesophageal junction to the
surrounding involuted fundic wall;
deactivating the engagement assembly to retract the needles from the
gastroesophageal junction and back into the needle-receiving lumens of the
introducer guide; and
removing the invagination device and the fastening assembly from the body
of the patient, and closing said operating channel port.
14. A device for invaginating the gastroesophageal junction of a patient,
said device comprising:
an introducer guide, said introducer guide having an outside diameter
approximating that of the esophagus;
engagement means for engaging the gastroesophageal junction of a patient,
said engagement means including a plurality of needles, said needles
having a retracted position in which said needles lie within said
introducer guide, and an extended position in which said needles extend
out of said introducer guide and projecting radially from said guide, said
engagement means further including means for projecting said needles out
of said introducer guide and into engagement with the esophagus in the
vicinity of the gastroesophageal junction.
15. The invagination device of claim 14 wherein said introducer guide
includes means for facilitating insertion into the esophagus.
16. The invagination device of claim 15 wherein said facilitation means
includes said guide being flexible along its length and tapered at its
distal end.
17. The invagination device of claim 14 wherein said needles, when in their
extended position, project radially and forwardly from said guide for
engagement with the gastroesophageal junction.
18. The invagination device of claim 15 wherein said needles, when in their
extended position, project radially and forwardly from said guide at an
angle of approximately 30.degree. in relation to the central axis of said
introducer guide.
19. The invagination device of claim 18 wherein said needles are
equidistantly spaced about the circumference of said introducer guide.
20. The invagination device of claim 19 wherein said engagement assembly
includes 10 needles equidistantly spaced about the circumference of said
introducer guide.
21. The invagination device of claim 14 wherein said introducer guide
includes means for facilitating the identification of the relative
positioning of said invagination device within the esophagus, said
position identifying means including an optical marking positioned at a
predetermined position on the exterior of said guide.
22. A device for invaginating the gastroesophageal junction of a patient,
said device comprising:
an introducer guide, said introducer guide having an outside diameter
approximating that of the esophagus, said guide further having a plurality
of needle-receiving lumens extending to the outer diametric surface of
said guide;
engagement means for engaging the gastroesophageal junction of a patient,
said engagement means including a plurality of needles, said needles
having a retracted position in which said needles lie within the
needle-receiving lumens of said introducer guide, and an extended position
in which said needles extend out of the lumens and project radially from
said guide, said engagement means further including means for projecting
said needles out of the needle-receiving lumens and into engagement with
the esophagus in the vicinity of the gastroesophageal junction.
23. The invagination device of claim 22 wherein said guide further has a
central lumen along its central axis, said plurality of needle-receiving
lumens extending from said central lumen to the outer diametric surface of
said guide; and wherein said engagement assembly includes a push rod, said
push rod being received by said central lumen and connected to said
plurality of needles, said push rod being axially movable within said
central lumen of said guide to project said needles out of the
needle-receiving lumens and into engagement with the gastroesophageal
junction.
24. The invagination device of claim 23 wherein said push rod defines a
central lumen through which a guide wire is receivable.
25. The invagination device of claim 22 wherein said introducer guide
includes means for facilitating insertion into the esophagus.
26. The invagination device of claim 25 wherein said facilitation means
include said guide being flexible along its length and tapered at its
distal end.
27. The invagination device of claim 22 wherein said needles, when in their
extended position, project radially and forwardly from said guide for
engagement with the gastroesophageal junction.
28. The invagination device of claim 27 wherein said needles, when in their
extended position, project radially and forwardly from said guide at an
angle of approximately 30.degree. in relation to the central axis of said
introducer guide.
29. The invagination device of claim 27 wherein said needles are
equidistantly spaced about the circumference of said introducer guide.
30. The invagination device of claim 28 wherein said engagement assembly
includes 10 needles equidistantly spaced about the circumference of said
introducer guide.
31. The invagination device of claim 23 wherein said push rod is threadedly
engagable with said introducer guide and where said threaded engagement
advances said push rod within said central lumen of said guide to project
said needles out of the needle-receiving lumens and into engagement with
the gastroesophageal junction.
32. The invagination device of claim 22 wherein said introducer guide
includes means for facilitating the identification of the relative
positioning of said invagination device within the esophagus, said
position identifying means including an optical marking positioned at a
predetermined position on the exterior of said guide.
33. The invagination device of claim 23 wherein said push rod includes an
interior metal core and an outer plastic tubing.
34. The invagination device of claim 26 wherein said introducer guide is
made of low density polyethylene.
35. A method for invaginating the gastroesophageal junction of a patient,
said method comprising the steps of:
implanting at least one operating channel/insufflation port, the operating
channel/insufflation port providing percutaneous access into the stomach
for a remotely operable fastening assembly through an operating channel,
and further providing a second access into the stomach for insufflating
the stomach through an insufflation lumen;
insufflating the stomach through the insufflation lumen of the implanted
operating channel/insufflation port;
introducing an invagination device transorally into the esophagus, the
invagination device including an introducer guide and an engagement
assembly; the introducer guide having an outside diameter approximating
that of the esophagus; the engagement assembly including means for
retractably engaging the esophagus in the vicinity of the gastroesophageal
junction;
activating the engagement assembly to engage the esophagus in the vicinity
of the gastroesophageal junction;
advancing the engaged invagination device toward the stomach to invaginate
the gastroesophageal junction into the stomach, involuting the surrounding
fundic wall;
introducing a remotely operable fastening assembly through the operating
channel of the implanted operating channel/insufflation port into the
stomach and operating the fastening assembly to secure the invaginated
gastroesophageal junction to the surrounding involuted fundic wall;
retracting the engagement assembly from engagement with the
gastroesophageal junction; and
removing the invagination device and the fastening assembly from the body
of the patient.
36. The method of claim 35 additionally including the steps of:
implanting a second operating port into the stomach, said second port
providing percutaneous access into the stomach for an endoscope through an
operating channel; and
introducing an endoscope through the operating channel of said second
implanted operating channel/insufflation port into the stomach and the
invagination device and the fastening assembly at the gastroesophageal
junction through the so introduced endoscope.
37. The method of claim 36 in which said second port further provides a
second access into the stomach for insufflating the stomach through an
insufflation lumen, and further including the step of insufflating the
stomach through said insufflation lumen of said second port.
38. The method of claim 35 additionally including the step of maintaining
fixation of the invaginated and secured gastroesophageal junction by the
leaving of said implanted port in place for a time after said removing of
the invagination device and fastening assembly.
39. An operating channel/insufflation port assembly comprising:
an operating channel/insufflation port member, said operating
channel/insufflation port member defining an operating channel sized to
receive remotely operable instrumentation, said port member further
defining an insufflation lumen connecting to an insufflation port located
on the exterior of said port member;
anchoring means for anchoring said port member in place extending
percutaneously into the stomach, with remotely operable instrumentation
being advanceable through said operating channel and into the stomach, and
with CO.sub.2 being passable into the stomach through said insufflation
lumen;
an insufflation valve member, connectable to said insufflation port, said
insufflation valve member including means for variably controlling the
supply of CO.sub.2 into the stomach through said insufflation lumen; and
operating channel sealing means for preventing gas leakage during
operation/insufflation, said sealing means including means for providing a
seal between said operating channel/insufflation port member and remotely
operable instrumentation received therethrough.
Description
BACKGROUND OF THE INVENTION
The present invention relates to the treatment of gastroesophageal reflux
disease. More specifically, the present invention relates to a new and
unique method for minimally-invasive invagination of the esophagus at the
gastroesophageal junction and to devices which are useful in this newly
developed procedure.
Patients with gastroesophageal reflux disease are prone to esophagitis,
ulceration, stricture formation and columnar metaplasia of the normal
squamous lining. The latter, termed Barretts esophagus, occurs in about
10% of patients with gastroesophageal reflux disease and is associated
with the presence of stricture, deep ulcers and the development of
adenocarcinoma. Gastroesophageal reflux disorders are diagnosed in over
500,000 people in the U.S. each year with only approximately 35,000
undergoing corrective anti-reflux.
There is a need for a new approach to the treatment of gastroesophageal
reflux disease that would be less invasive than general surgical
techniques and more cost-effective than chronic acid reduction therapy.
The availability of such a procedure would lead to earlier and more
widespread referral for corrective surgery and thus the avoidance of
severe complications caused by progression of the disease while undergoing
long term medical therapy.
SUMMARY OF THE INVENTION
Generally speaking, the present invention provides a new and improved
method for treating gastroesophageal reflux by the endoscopic construction
of a fundoplication, and to new devices which are useful in this new
technique. According to one embodiment of the method, an invagination
device is introduced transorally into the esophagus. The invagination
device includes an introducer guide which has an outside diameter
approximating that of the esophagus and a plurality of needle-receiving
lumens extending to its outer diametric surface. The invagination device
also has an engagement assembly which includes a number of needles. These
needles each have a retracted position in which they lie within the
needle-receiving lumens and project radially from the guide for engagement
with the esophagus. The engagement assembly is then activated to place the
needles in their extended position in engagement with the esophagus, and
the engaged invagination device is advanced toward and into the stomach to
invaginate the gastroesophageal junction into the stomach for a distance
of 3-4 cm. A remotely operable fastening assembly is introduced into the
stomach through a previously implanted operating channel/insufflation
port, and operated to fasten the invaginated esophagus to the adjacent
involuted stomach. This is performed by sliding one arm of the fastening
assembly into preformed grooves in the surface of the invagination device
and placing the other arm over the involuted stomach, then stapling the
invaginated esophageal wall to the involuted gastric wall in a
non-crushing manner. After this "nipple" valve has been secured by the
fastening assembly, the needles are retracted back into their
needle-receiving lumens, and the invaginated device and the fastening
assembly are removed. The implanted operating channel/insufflation ports
are sealed and left in place for a period of time after removal of the
other instrumentation in order to maintain fixation of the newly formed
valve.
This new minimally-invasive approach accomplishes the formation of a new
valve between the esophagus and stomach, thus preventing acid refluxation.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1a-d conceptually illustrate sequential stages in the performance of
an invagination technique according to the present invention. FIG. 1a
shows an invagination device that has been advanced into the esophagus and
positioned at the gastroesophageal junction. FIG. 1b shows the
invagination device of FIG. 1a with its engagement assembly having been
activated to extend a plurality of needles into engagement with the
esophagus near the esophageal junction (engagement of needles should be
made as close to the gastroesophageal junction as practicable). FIG. 1c
shows the engaged invagination device having been advanced toward the
stomach to invaginate the esophageal wall at the gastroesophageal
junction, and further illustrate the invaginated gastroesophageal junction
being fastened into place. Lastly, FIG. 1d shows the newly formed valve
between the esophagus and the stomach, with the invagination device and
other equipment having been removed.
FIGS. 2a-b show partially fragmented and segmented side elevational views
of the invagination device used in the described method. FIG. 2a shows the
device with its engagement assembly deactivated, the engagement needles
being retained within their respective lumens. FIG. 2b shows the device
with its engagement assembly activated to project the needles from their
respective lumens for engagement with the esophageal wall.
FIGS. 3a-d illustrate an operating channel/insufflation assembly which
provides percutaneous access into the stomach for introduction of a
remotely operable fastener and/or endoscope, and also provides for the
insufflation of the stomach. FIGS. 3a is a side elevational view of a
complete assembly. FIGS. 3b-d illustrate enlarged cross-sectionals view of
portions of the assembly at various stages of operation. FIG. 3b shows an
implanted operating channel/insufflation port 110, balloon inflation
nozzle 130, and insufflation valve 140, with nozzle 130 and valve 140
detached from their respective connection ports. In FIG. 3c, tapered
portion 111 of port 110 has been severed, and fastening assembly 50 has
been inserted through central operating channel 114. Also in FIG. 3c,
insufflation valve 140 has been attached to insufflation port 115 for
insufflation of the stomach through insufflation lumen 116, and sealing
member 150 has been placed about port 110 and positioned in sealing
engagement with fastening assembly 50, thus preventing gas leakage through
operating channel 114 during the operation/insufflation. In FIG. 3d,
fastening assembly 50 has been removed, insufflation valve 140 has been
detached, and seal cap 160 has been placed about port 110, sealing access
to and from the stomach.
In the same manner as FIGS. 1a-d, FIGS. 4a-d illustrate sequential stages
in the performance of an invagination technique according to the present
invention in conjunction with an alternatively configured invagination
device. FIG. 4a shows the invagination device advanced into the esophagus
and positioned at the gastroesophageal junction. FIG. 4b shows the
invagination device of FIG. 4a with its engagement assembly having been
activated to extend a plurality of needles into engagement with the
esophagus at the esophageal junction. FIG. 4c shows the engaged
invagination device having been advanced toward the stomach to invaginate
the esophageal wall at the gastroesophageal junction, and further
illustrate the invaginated gastroesophageal junction being fastened into
place. Lastly, FIG. 4d shows the newly formed valve between the esophagus
and the stomach, with the invagination device and other equipment having
been removed.
FIGS. 5a-b are enlarged illustrations, showing the changes in configuration
with respect to the invagination device 70' used in relation to FIGS.
4a-d. FIG. 5a shows an enlarged end view of invagination guide 70',
illustrating the circumferential spacing of lumens 78' and grooves 72'.
FIG. 5b is an enlarged fragmented side elevational view of invagination
guide 70' showing groove 72' extending past lumens 78'.
DESCRIPTION OF THE PREFERRED EMBODIMENT
For the purposes of promoting an understanding of the principles of the
invention, reference will now be made to the embodiment illustrated in the
drawings and specific language will be used to describe the same. It will
nevertheless be understood that no limitation of the scope of the
invention is thereby intended, such alterations and further modifications
in the illustrated device, and such further applications of the principles
of the invention as illustrated therein being contemplated as would
normally occur to one skilled in the art to which the invention relates.
The preferred embodiment of the method of the present invention will now be
described with reference to FIGS. 1a-d which illustrate sequential stages
in the performance of this invagination technique at the gastroesophageal
junction 10 which anatomically connects the esophagus 20 to the stomach
30.
Preliminarily, two operating channel/insufflation ports are percutaneously
opened into the stomach 30, one port being sized to accommodate an
endoscope (7 mm), and the second port being about 12 mm in diameter to
accommodate a remotely operable fastening assembly. This is generally
accomplished by 1) percutaneously introducing a guide wire into the
stomach, 2) using an endoscopic to snare the guide wire and retract it
through the mouth, 3) advancing a graduated dilator operating channel port
assembly transorally over the guide wire under tension and partially out
through the skin, and 4) anchoring the assembly into place. The steps of
this aspect of the procedure will be more fully discussed later in this
specification in relation to FIGS. 3a-d.
After the stomach has been insufflated through the insufflation lumens of
the previously implanted ports, another needle is placed through the
abdominal wall into the stomach and under endoscopic guidance a guide wire
5 is introduced and pulled out the mouth. Invagination device 70 is then
passed over guide wire 5 and into esophagus 20. The introduction and
advancement of invagination device 70 into esophagus 20 is facilitated by
the flexibility of device 70 along its length and by the tapered shape of
its distal end. Guidance of device 70 through esophagus 20 can be further
facilitated by the application of appropriate tension on guide wire 5
while device 70 is being advanced. A 5 mm laparoscope 40 is introduced
through the 7 mm port and invagination device 70 is positioned, under
direct observation by laparoscope 40, at the anatomical gastroesophageal
junction 10. The location of invagination device 70 in relation to
gastroesophageal junction 10 is facilitated by the affixation of a marking
71 at a predetermined distance (3 cm) from the distal end of device 70.
FIG. 1a shows invagination device 70 having been advanced into esophagus
20 and so positioned at the gastroesophageal junction 10.
The engagement assembly of invagination device 70 is then activated to
advance needles 88 out through lumens 78 to project radially and forwardly
from invagination device 70 and into engagement with esophagus 20. The
mechanism for projecting needles 88 into engagement with esophagus 20 will
be described more specifically later in this specification in relation to
FIGS. 2a-b. FIG. 1b shows invagination device 70 with its engagement
assembly having been so activated to extend needles 88 into engagement
with esophagus 20 in the vicinity of the gastroesophageal junction. It is
to be noted that FIG. 1b conceptually shows this engagement and is not
drawn to scale. In practice, the engagement of needles 88 with esophagus
20 should be made as close to esophageal junction 10 as practicable. Most
preferably, engagement should be made directly at the gastroesophageal
junction 10 in order to prevent long term exposure of the esophogeal inner
lining to the stomach secretions.
Once so engaged, invagination device 70 is pushed forward toward stomach
30, which movement forces esophagus 20 toward stomach 30 to invaginate the
gastroesophageal junction 10 and involute the surrounding fundic wall 25.
A 10 mm remotely operable stapling device 50 is then advanced through the
previously opened 12 mm operating channel/insufflation port, and operated
to staple fundic wall 25 to the invaginated gastroesophageal junction 10.
Grooves 72 at the tapered distal portion of introducer guide 75 serve to
facilitate the stapling action of stapler 50 by providing a stable backing
therefor. FIG. 1c shows engaged invagination device 70 having been
advanced toward stomach 30 to so invaginate gastroesophageal junction 10,
and FIG. 1c further illustrates fundic wall 25 being fastened to the
invaginated gastroesophageal junction 10 by stapler 50.
Lastly, stapler 50 is removed, needles 88 are retracted back into their
respective lumens 78, and invagination device 70 and guide wire 5 are
removed. Laparoscope 40 is also removed. Operating channel/insufflation
ports then sealed and are kept in place for a period of time to maintain
fixation of the newly formed valve. FIG. 1d shows the newly formed valve
between esophagus 20 and stomach 30, with invagination device 70 and other
instrumentation having been removed, and with staples 55 holding fundic
wall 25 to the gastroesophageal junction 10. It is believed that two or
three rows of staples 55 should be sufficient to hold the formed fold in
place and maintain the functionality of the so formed valve.
Invagination device 70 will now be discussed in specific detail in relation
to FIGS. 2a-b, which show partially fragmented and segmented side
elevational views of this device which is used in the above described
method. FIG. 2a shows the device with its engagement assembly deactivated,
the engagement needles being retained within their respective lumens. FIG.
2b shows the device with its engagement assembly activated to project the
needles from their respective lumens for engagement with the esophageal
wall.
Invagination device 70 includes introducer guide 75 which has an outside
diameter approximating that of the esophagus. Introducer guide 75 is made
with material that is biocompatible and flexible (low density polyethylene
is particularly suited for this purpose), and is tapered at its distal end
to facilitate insertion and advancement into the esophagus. Introducer
guide 75 defines a central lumen 76, extending the length thereof, through
which a guide wire is receivable. The central lumen 76 of introducer guide
75 also accommodates needle projector 80. Extending from central lumen 76
in introducer guide 75 are ten needle-receiving lumens 78, which are
equidistantly spaced about the circumference of introducer guide 75 and
extend to the outer diametric surface thereof. At the proximal end of
introducer guide 75 is a male threaded connector 77.
Invagination device includes an engagement assembly which can be activated
to project needles 88 out of their respective needle-receiving lumens 78
and into engagement with the esophagus. This engagement assembly for
projecting needles 88 includes needle projector 80, advancing member 90,
and connector 77.
Needle projector 80 has a metal hub 81 at its distal end to which needles
88 are connected. At its proximal end, needle projector 80 has a second
metal hub 82 which is seated within recess 93 of advancing member 90.
Extending along its length, the shaft 83 of needle projector 80 has a
metallic interior core 84 and a plastic outer tubing 85. Metallic interior
core 84 defines a central lumen 86 therein through which a guide wire is
receivable. Metallic interior core 84 is made of stainless steel and
provides axial strength and rigidity to shaft 83, while plastic outer
tubing 85, which is constructed from low to medium density polyethylene,
enhances the flexibility of shaft 83 and provides for laterally stability
within the central lumen 76 of introducer guide 75. Together, hubs 81 and
82 and shaft 83 form a "push rod" which, when advanced within central
lumen 76 of guide 75, projects needles 88 out of their respective
needle-receiving lumens 78 and into engagement with the esophagus.
The advancement of projector 80 within central lumen 76 is accomplished by
the operation of advancing member 90. Advancing member 90 has, at its
distal end, a female threaded portion 91 which threadedly engages the male
threaded portion 79 of connector 77 and, at its proximal end, retaining
portion 92 which retains hub 82 within recess 93. Central lumen 96 through
advancing member 90 receives shaft 83 and proximal hub 82 of needle
projector 80, and continues through the proximal end of advancing member
90 to allow a guide wire to be passed through the entire length of
invagination device 70.
By threading advancing member 90 over connector 77 of introducer guide 75,
needle projector 80 is advanced within introducer guide 75 to project
needles 88 out through needle-receiving lumens 78, extending needles 88
radially and forwardly about the circumference of device 70 for engagement
with the esophagus. When advancing member 90 is fully threadedly engaged
over connector 77, needles 88 are fully extended from introducer guide 75.
By the use of the threaded engagement for advancement, needles 88 are
projected smoothly and evenly to provide for a steady and sure engagement
with the esophageal wall. Needles 88 are guided by needle-receiving lumens
88 out at an angle of about 30.degree. to the longitudinal axis of device
70. Ten needles, equidistantly spaced about the circumference of device
70, 36.degree. apart, at this projection angle of 30.degree., have been
found to be sufficient to stably engage and advance the esophageal wall.
An operating channel/insufflation port assembly useful for the introduction
of laparoscope 40 and remotely operable stapling assembly 50 will now be
discussed in specific detail in relation to FIGS. 3a-d. Operating
channel/insufflation port assembly 100 includes guide wire 105, operating
channel/insufflation port 110, skin flange 120, attachable balloon
inflator nozzle 130, attachable insufflation valve 140, sealing member
150, and seal cap 160.
Procedurally, guide wire 105 is first percutaneously introduced into the
stomach, and an endoscope is introduced transorally into the stomach and
used to snare guide wire 105 and retract it through the mouth. Operating
channel/insufflation port 110 is then transorally advanced over guide wire
105 under tension and partially out through the skin. After removing guide
wire 105, skin flange 120 is placed over the tubular portion of port 110
and advanced toward the skin. Attachable balloon inflator nozzle 130 is
then attached to inflation port 112 and CO.sub.2 is injected therethrough
and into balloon 118, through inflation lumen 113 which is connected
thereto, thus inflating balloon 118 in place within the stomach. Skin
flange 120 is then adjusted against the skin to secure port 110 into
place. The tapered distal portion 111 of operating channel/insufflation
port 110 is then cut off at mark 111', thereby opening access into the
stomach through operating channel 114.
When connected to insufflation port 115, insufflation valve 140 is operated
to provide a supply of CO.sub.2 into the stomach through insufflation
lumen 116 and out insufflation opening 117. By turning cock 142, the
supply of CO.sub.2 into the stomach may be variably controlled and
adjusted as needed.
Operating channel/insufflation port 110 is preferably made of flexible
material which matches the elasticity of the tissue surrounding it when
implanted. Silicone is believed to be particularly suited for this
purpose. To provide additional strength and stability during implantation,
tapered portion 111 of port 110 has a lumen 104 of only enough size to
receive wire guide 105. As previously discussed, tapered portion 111 is
severed after implantation to expose central operating channel 114,
thereby providing access into the stomach for remotely operable
instrumentation which is to be used in conjunction with the operation to
be performed.
Skin flange 120 is also made of silicone, and includes of a disc shaped
flange 121 and a tubular handle portion 122. Slot 123 facilitates the
advancing of flange 120 along port 110. Seal cap 150 seals the end of port
110, attaching thereabout to form a sealing fit between detent 151 of seal
cap 150 and indentation 119 of port 110.
FIGS. 3b-d illustrate enlarged cross-sectional views of portions of the
assembly at various stages of operation. FIG. 3b shows an implanted
operating channel/insufflation port 110, balloon inflation nozzle 130, and
insufflation valve 140, with nozzle 130 and valve 140 detached from their
respective connection ports. In FIG. 3b it can be seen that tapered
portion 111 has a central lumen 104 sized only to receive guide wire 105,
thus providing additional strength and stability during implantation,
while tubular portion 110a defines an enlarged operating channel 114,
sized to receive remotely operable instrumentation (12 mm, for example,
for a fastening assembly, and 7 mm, for a laparoscope). Within the walls
of said tubular portion 110a are defined a balloon inflation port 112 and
balloon inflation lumen 113 which connects port 112 to the interior of
balloon 118. At the entrance of port 112 is seal 112a. Also defined within
the walls of tubular portion 110a is an insufflation lumen 116, connecting
exterior insufflation port 115 to interior insufflation port 117. At the
entrance of port 115 is seal 115a.
Also shown in FIGS. 3b-d are partial cross-sectional views of balloon
inflation nozzle 130 and insufflation valve 140, which are connectable to
ports 112 and 115 respectively. When placed into port 115, as shown in
FIG. 3c, seal 115a is opened, allowing CO.sub.2 to be injected into the
stomach through valve passageway 141 and insufflation lumen 116. When
valve 140 has been removed from port 115, as shown in FIG. 3d, seal 115a
recloses. Balloon inflation nozzle 130 operates in the same manner in
relation to port 112 to inflate balloon 118 through passageway 131 and
inflation lumen 113.
In FIG. 3c, tapered portion 111 of port 110 has been severed, and fastening
assembly 50 has been inserted through central operating channel 114. Also
in FIG. 3c, insufflation valve 140 has been attached to insufflation port
115 for insufflation of the stomach through insufflation lumen 116.
Sealing member 150 has been placed about port 110 and positioned in
sealing engagement with fastening assembly 50, thus preventing gas leakage
through operating channel 114 during operation/insufflation. Detent 151 of
sealing member 150 fits in indentation 119 of port 110 in sealing
engagement, while interior flange 152 forms a sealing engagement with
fastening assembly 50 to effectly prevent leakage.
In FIG. 3d, fastening assembly 50 has been removed, insufflation valve 140
has been detached, and seal cap 160 has been placed about port 110,
sealing access to and from the stomach. So sealed, port 110 may be kept
implanted for a period of time after completion of the above described
operation in order to maintain fixation of the stomach to the peritoneum
and also provides a drainage port for the stomach.
In the same manner as FIGS. 1a-d, FIGS. 4a-d illustrate sequential stages
in the performance of an invagination technique according to the present
invention in conjunction with an alternatively configured invagination
device. Except as otherwise noted, all aspects of FIGS. 4a-d are the same
as FIGS. 1a-d, with the primed notations of FIGS. 4a-d corresponding the
same relative unprimed notations of FIGS. 1a-d. Therefore, to avoid
redundancy the description of these additional drawings will not be
repeated except to the extent of the following differences.
Specifically, in FIGS. 4a-b it is to be noted that groove 72' extends
longitudinally from the beginning of the taper in guide 70' proximally
past lumens 78' and that lumens 78' have been reconfigured to provide room
for groove 72' to extend therepast. This revised configuration facilitates
placement of the anvil jaw of fastening assembly 50' within the esophgeal
lumen and allows fastening assembly 50' to be positioned past needles 88'
during stapling, as shown in FIG. 4c, thus allowing the needle engagement
to be made directly at the gastroesophogeal junction 10. Engagement
directly at the gastroesophageal junction 10 prevents long term exposure
of the esophogeal inner lining to the stomach secretions.
FIG. 5a shows an enlarged end view of invagination guide 70', illustrating
the circumferential spacing of lumens 78' and grooves 72'. FIG. 5b is an
enlarged fragmented side elevational view of invagination guide 70'
showing groove 72' extending past lumens 78'.
While the invention has been illustrated and described in detail in the
drawings and foregoing description, the same is to be considered as
illustrative and not restrictive in character, it being understood that
only the preferred embodiment has been shown and described and that all
changes and modifications that come within the spirit of the invention are
desired to be protected.
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